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The Risk of HIV Acquisition Among Traditional Healers in South Africa

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ClinicalTrials.gov Identifier: NCT04440813
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
Carolyn Audet, Vanderbilt University Medical Center

Brief Summary:
Traditional healers, community-based partners with the national health system of South Africa, are exposed to patient blood an average of 1,500 times during their careers due to the practice of delivering herbal remedies via herbs rubbed into dozens of sub-cutaneous cuts. The purpose of this proposal is to compare two implementation strategies to increase consistent use of Personal Protective Equipment (PPE): (1) a health care worker provided training program followed by 3 educational outreach and coaching visits at the healer's place of practice vs. (2) a training and educational outreach initiative led by a team of health care workers and healers who adopted and use PPE on their own (early adopters) to assess their effects on exposure to patient blood. With an HIV prevalence among healers well above that in the baseline population (30% vs. 19%) and HIV prevalence of 59% among those exposed to patient blood, this study will allow the investigators to test a novel implementation strategy for delivering PPE training to prevent new HIV infections among a newly identified high-risk population in a region with the world's highest HIV prevalence.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Education and Training by Clinicians Behavioral: Training and Education from Traditional Healers and Clinicians Not Applicable

Detailed Description:

In South Africa there are an estimated 200,000 traditional healers providing health services. Like allopathic health care workers (HCW), traditional healers are exposed to bloodborne pathogens through the widespread practice of traditional "injections", where healers perform dozens of subcutaneous incisions to rub herbs directly into the bloodied skin. Ninety-eight percent of healers perform these treatments; they experience an average of 1,500 blood exposures over the course of their lifetime. This high frequency of blood exposure, coupled with treating high risk patients, can result in increased risk of patient-to-healer disease transmission if personal protective equipment (PPE) are not used. Healers in South Africa who reported patient blood touched their skin had 2.59 times higher risk of being HIV-positive than those with no exposure (59% vs. 25%); overall healers have a substantially higher HIV prevalence (30%) than the general population (19%).

Free PPE are made available at local health facilities, but most healers have low levels of literacy, limited ability to assess blood exposure risk, and have no PPE training. Given these limitations, use of PPE during treatments is inconsistent. A small proportion of healers employ PPE appropriately during each treatment; these "early adopter" healers suggest PPE use is sustainable in rural sub-Saharan Africa if a healer has the necessary skills, risk assessment training, and encouragement. This proposal compares two implementation strategies to increase PPE use during procedures and decrease the number of injections performed: (1) HCW led education on risk of blood exposure and development of PPE donning, use and doffing skills though a week-long training followed by 3 educational outreach visits at the healer's place of practice vs. (2) "Early adopter" healer and HCW co-led week-long training followed by 3 educational outreach visits. The investigators hypothesize that the strategy of engaging "early adopter" healers as trainers will lead to more accurate participant risk assessments, increase participant self-efficacy, and lead to more consistent use of PPE during treatments.

The Specific Aims of this study are to:

  1. Adapt PPE training using the "ADAPT-ITT" model;
  2. Compare fidelity of PPE training between the HCW-only team versus the healer + HCW team;
  3. Compare the effects of two implementation strategies on healer exposure to patient blood.

This potentially high-impact intervention is well-suited to the R21 mechanism. While some allopathic providers may recommend an outright ban on the procedure, patients and healers have strongly believed in the efficacy of these treatments for hundreds of years- they are not likely to stop because of a Department of Health recommendation. It is up health care workers and governments to overcome their own biases to develop an effective strategy to prevent HIV seroconversion. The team of South African and U.S. investigators has a proven record of HIV research success and specific experience successfully engaging traditional healers, HIV prevention studies, as well as, dissemination and implementation research.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Risk of HIV Acquisition Among Traditional Healers in South Africa: Implementing Novel Strategies to Improve Protective Behaviors
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Clinician Training
Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel.
Behavioral: Education and Training by Clinicians
Training in the use of PPE and education about the risks of blood exposure.

Experimental: Healer + Clinician Training
Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel.
Behavioral: Training and Education from Traditional Healers and Clinicians
Training in the use of PPE and education about the risks of blood exposure.




Primary Outcome Measures :
  1. Blood exposure [ Time Frame: 7 months ]
    1) Collect used sharps and PPE. Healers will be given containers to place all use used gloves and razors/sharps to both ensure healer safety and allow us to count materials used (healers use gloves and a single razor once per patient and subsequently throw them into latrines or trash piles.). We will use the number of glove pairs as the numerator (number of times they used gloves during procedures) and the number of razor blades as the denominator (number of injections given).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Traditional healers > 18 years of age, who are registered as traditional healers with the government of South Africa, are currently practicing in the Bushbuckridge area, and conduct traditional vaccinations.
  2. Biomedical practitioners > 18 years of age, who are currently providing health care services to patients at government or private health facilities in Bushbuckridge. '
  3. Community members > 18 years of age, who currently live in Bushbuckridge and sought health care services from a traditional healer in the past year.

Exclusion Criteria:

  1. Traditional healers <18 years of age, who are not registered as traditional healers with the government of South Africa, are not currently practicing, or do not conduct traditional vaccinations on their patients.
  2. Biomedical practitioners < 18 years of age or who are not currently providing health services in the Bushbuckridge area.
  3. Community members < 18 years of age or who do not seek health care services from traditional healers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440813


Contacts
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Contact: Carolyn M Audet, PhD +16154809009 carolyn.m.audet@vanderbilt.edu
Contact: Ryan Wagner, PhD +27715860906 Ryan.Wagner@wits.ac.za

Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Allergy and Infectious Diseases (NIAID)
University of Witwatersrand, South Africa
Investigators
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Principal Investigator: Carolyn M Audet, PhD Vanderbilt University
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Responsible Party: Carolyn Audet, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04440813    
Other Study ID Numbers: R21AI150302 ( U.S. NIH Grant/Contract )
R21AI150302-01 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases